{"title":"新型COVID-19提案主题专家委员会会议纪要评价。","authors":"Jeffrey Pradeep Raj, Ambika Mamde, Keya Ganatra, Nithya Jaideep Gogtay, Urmila Mukund Thatte","doi":"10.4103/picr.picr_159_21","DOIUrl":null,"url":null,"abstract":"We analyzed minutes of the SEC meetings on COVID-19 (April 8, 2020–January 31, 2021) and excluded items that were postponed/deferred or were internal discussions. Each item was classified as initial/ repeat application; category of the interventional product was classified as repurposed/novel and the therapeutic area was noted down. The purpose of the application was classified as permission to conduct computed tomography [CT]/amendment of approved protocol/ Marketing authorization (MA) with CT waiver or MA post-CT].","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"13 3","pages":"172-173"},"PeriodicalIF":0.0000,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/0a/6f/PCR-13-172.PMC9345249.pdf","citationCount":"0","resultStr":"{\"title\":\"An evaluation of the minutes of subject expert committee meetings of novel COVID-19 proposals.\",\"authors\":\"Jeffrey Pradeep Raj, Ambika Mamde, Keya Ganatra, Nithya Jaideep Gogtay, Urmila Mukund Thatte\",\"doi\":\"10.4103/picr.picr_159_21\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"We analyzed minutes of the SEC meetings on COVID-19 (April 8, 2020–January 31, 2021) and excluded items that were postponed/deferred or were internal discussions. Each item was classified as initial/ repeat application; category of the interventional product was classified as repurposed/novel and the therapeutic area was noted down. The purpose of the application was classified as permission to conduct computed tomography [CT]/amendment of approved protocol/ Marketing authorization (MA) with CT waiver or MA post-CT].\",\"PeriodicalId\":20015,\"journal\":{\"name\":\"Perspectives in Clinical Research\",\"volume\":\"13 3\",\"pages\":\"172-173\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2022-07-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/0a/6f/PCR-13-172.PMC9345249.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Perspectives in Clinical Research\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.4103/picr.picr_159_21\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2022/1/11 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Perspectives in Clinical Research","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.4103/picr.picr_159_21","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2022/1/11 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"Medicine","Score":null,"Total":0}
An evaluation of the minutes of subject expert committee meetings of novel COVID-19 proposals.
We analyzed minutes of the SEC meetings on COVID-19 (April 8, 2020–January 31, 2021) and excluded items that were postponed/deferred or were internal discussions. Each item was classified as initial/ repeat application; category of the interventional product was classified as repurposed/novel and the therapeutic area was noted down. The purpose of the application was classified as permission to conduct computed tomography [CT]/amendment of approved protocol/ Marketing authorization (MA) with CT waiver or MA post-CT].
期刊介绍:
This peer review quarterly journal is positioned to build a learning clinical research community in India. This scientific journal will have a broad coverage of topics across clinical research disciplines including clinical research methodology, research ethics, clinical data management, training, data management, biostatistics, regulatory and will include original articles, reviews, news and views, perspectives, and other interesting sections. PICR will offer all clinical research stakeholders in India – academicians, ethics committees, regulators, and industry professionals -a forum for exchange of ideas, information and opinions.